Ipsen is pleased to announce that the US Food and Drug Administration (FDA) has approved a new device to deliver Somatuline® Depot to patients with acromegaly. The enhanced device with Safe’n’Sound® syringe technology will continue to offer a streamlined injection process with its prefilled, low-volume syringe that supports full delivery of your dose and is ready to use without mixing.

The syringe is available in 60-mg, 90-mg, and 120-mg doses and will offer several additional benefits:

It may have begun with a variety of seemingly disconnected symptoms: enlarged tongue, nose, or lips; headaches; or excessive sweating. Over time you may have noticed abnormal bone growth or enlargement in your face, hands, or feet; your joints aching; abnormal weight gain; prognathism (an enlargement of the lower jaw); or sleep apnea.

After a great deal of frustration over a lack of answers, you may have finally been diagnosed with acromegaly, a rare condition that is usually due to the pituitary gland located at the base of the brain releasing too much growth hormone (GH) into the bloodstream.

Being diagnosed with acromegaly can be disconcerting and confusing. It can also be an important step toward managing your disease with proper treatment.

Although acromegaly can’t always be cured, it can often be managed with proper treatment. Somatuline Depot is a long-term acromegaly therapy that offers proven reductions of GH and insulin-like growth factor 1 (IGF-1), the hormones that cause acromegaly.

What is Somatuline® Depot (lanreotide) Injection?

Somatuline Depot is a prescription medicine used for the long-term treatment of acromegaly when surgery or radiotherapy has not worked well enough or the patient is not able to have surgery or radiotherapy.

It is not known if Somatuline Depot is safe and effective in children.

Important Safety Information

Who should not take Somatuline Depot?

Do not take Somatuline Depot if you are allergic to lanreotide.

What are the possible side effects of Somatuline Depot?

Somatuline Depot may cause serious side effects, including:

Gallstones. Tell your healthcare professional if you get any of these symptoms:

The most common side effects of Somatuline Depot in people with acromegaly include diarrhea, stomach area (abdominal) pain, nausea, and pain, itching, or a lump at the injection site.

Somatuline Depot may cause dizziness. If this happens, do not drive a car or operate machinery.

What should I tell my healthcare professional before receiving Somatuline Depot?

Tell your healthcare professional if you have diabetes or gallbladder, thyroid, heart, kidney, or liver problems

Tell your healthcare professional if you are pregnant or plan to become pregnant as Somatuline Depot may harm your unborn baby. Tell your healthcare professional if you are breastfeeding or plan to breastfeed. It is not known if Somatuline Depot passes into your breast milk. You and your healthcare professional should decide if you will take Somatuline Depot or breastfeed. You should not do both

Tell your healthcare professional about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Somatuline Depot and other medicines may affect each other, causing side effects. Somatuline Depot may affect the way other medicines work, and other medicines may affect how Somatuline Depot works

Especially tell your healthcare professional if you take insulin or other diabetes medicines, a cyclosporine (Gengraf, Neoral, or Sandimmune), a medicine called bromocriptine (Parlodel, Cycloset), or medicines that lower your heart rate, such as beta blockers

Tell your healthcare professional if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Somatuline Depot. For more information ask your healthcare professional.

You may report side effects to FDA at 1-800-FDA-1088 or Ipsen Biopharmaceuticals, Inc.
at 1-888-980-2889.

What is Somatuline® Depot (lanreotide) Injection?

Somatuline Depot is a prescription medicine used for the long-term treatment of acromegaly when surgery or radiotherapy has not worked well enough or the patient is not able to have surgery or radiotherapy.

It is not known if Somatuline Depot is safe and effective in children.

Important Safety Information

Who should not take Somatuline Depot?

Do not take Somatuline Depot if you are allergic to lanreotide.

What are the possible side effects of Somatuline Depot?

Somatuline Depot may cause serious side effects, including:

Gallstones. Tell your healthcare professional if you get any of these symptoms:

The most common side effects of Somatuline Depot in people with acromegaly include diarrhea, stomach area (abdominal) pain, nausea, and pain, itching, or a lump at the injection site.

Somatuline Depot may cause dizziness. If this happens, do not drive a car or operate machinery.

What should I tell my healthcare professional before receiving Somatuline Depot?

Tell your healthcare professional if you have diabetes or gallbladder, thyroid, heart, kidney, or liver problems

Tell your healthcare professional if you are pregnant or plan to become pregnant as Somatuline Depot may harm your unborn baby. Tell your healthcare professional if you are breastfeeding or plan to breastfeed. It is not known if Somatuline Depot passes into your breast milk. You and your healthcare professional should decide if you will take Somatuline Depot or breastfeed. You should not do both

Tell your healthcare professional about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Somatuline Depot and other medicines may affect each other, causing side effects. Somatuline Depot may affect the way other medicines work, and other medicines may affect how Somatuline Depot works

Especially tell your healthcare professional if you take insulin or other diabetes medicines, a cyclosporine (Gengraf, Neoral, or Sandimmune), a medicine called bromocriptine (Parlodel, Cycloset), or medicines that lower your heart rate, such as beta blockers

Tell your healthcare professional if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Somatuline Depot. For more information ask your healthcare professional.

You may report side effects to FDA at 1-800-FDA-1088 or Ipsen Biopharmaceuticals, Inc.
at 1-888-980-2889.